Associate Director/Director QA
A leading biotechnology company working to create first-in-class biological therapies to address unmet patient needs in oncology, is seeking an Associate Director/Director QA. Based in the UK, this is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- To oversee, manage and lead the Quality Assurance Department and take the lead to ensure the company is fully compliant with all appropriate regulatory authorities.
- To lead and promote joined up quality thinking and decision making across all internal and external operations.
- To build a high performing, motivated and skilled Quality team capable of delivering to the standards required.
- To lead by example, inspire the Quality team to outperform.
- To take full accountability for the Quality and Compliance activities for the UK and US teams.
- To take lead to ensure the company is fully compliant as a marketing authorisation holder, meeting regulatory and quality standards whilst maintaining compliance to GXP and license commitments.
- To take lead on and full accountability for the company's Quality Assurance Management System.
- To assume the Site Subject Matter Expert role, liaising directly with internal and external customers on all subjects related to Quality.
- To oversee the Regulatory Authority and Audit Inspections and ensure company is prepared for these inspections.
- To promote and embed a culture of Quality Assurance excellence and readiness for inspection throughout the company's and its partner organisations.
- To ensure the company is compliant with all regulatory requirements and legislation.
- To ensure all activities, processes and procedures are carried out to the highest quality and accuracy standards and in line with industry standards and compliance guidelines.
- To ensure full GXP compliance is delivered and maintained across the company.
- To conduct external audits of existing contract manufacturers and suppliers and conduct vendor assessment/selection for all new manufacturers, suppliers and providers.
- To develop and maintain and champion electronic QMS system to track and store all of the key elements related to QA (training, QE, NC, CAPA, RCA, etc)
- To liaise with the QA team and oversee all aspects of Change Control and deviations from specification and the validation required before changes can be implemented.
- To liaise with the HA where appropriate to ensure that the Company conforms to the requirements of GMP and associated manufacturing
- To coordinate the preparation and hosting of inspections by global Health Authorities
- To provide documented feedback relating to all audits and ensure standards are applied and met with follow up training programs and improvements to QA best practice and process within the company.
- To promote a culture where people are focused on quality, compliance, and inspection readiness by design from the start of any company process and to keep the senior leadership informed of any problems relating to QA issues.
Skills and Requirements:
- Support and develop Company Training sessions regarding Quality and Compliance in order to promote a culture of quality and compliance.
- Follow and complete the Company Induction Training Schedule, adhering to SOP training and GXP training requirements.
- Ensure all company training requirements are kept up to date with the evolving business knowledge, skills and regulatory requirements.
- Deep experience in QA at the global level of a biopharma company
- Able to develop and lead a QA team responsible for ensuring GXP compliance across all functional areas.
- Analytical Thinking - Tackling problems using a logical, systematic and sequential approach, identifying discrepancies and inconsistencies.
Management and Leadership
- Strong leadership qualities: to embody the culture and values of the business, to be highly effective as a team motivator and coach.
- First rate interpersonal skills (both written and verbal): an ability to assertively represent the business at the highest level on the one hand, and to communicate and be approachable to all members of the team on the other.
- Resilience: an ability to remain calm and organised under pressure.
- Methodical and process orientated.
- Detailed approach to planning, execution, detail focused, clear thinker.
Excellent documentation skills
- A strong team player with the ability to respond to others in a supportive and flexible manner.
- Continuous Improvement of all Quality operations: an ability to self-audit.
- To adhere to the highest levels of integrity, professionally and personally.
- Highly commercial/business acumen.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Katty Maia on +44 203 854 3317 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.